IVDD – Article 12

The regulatory authorities in the EU are getting much better at managing the flow of information as it pertains to device manufacturers, device registration, certificates, and vigilance reporting. Prior to May 2011, use of the EUDAMED was strictly voluntary; now, however, it is mandatory and the Competent Authorities, from each of the Member States, are required to input data into the databank.

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HAPPY NEW YEAR! Dr. D would like to welcome the readers back from the Holiday break and hope each of you had a great start to the New Year.

Speaking of the New Year, I am hoping that many of you can join me at the Medical Device Summit’s Supplier Controls and Quality Management Conference on January 19th and 20th in Washington, D.C. (Marriott – Wardman Park). Last year’s event was spectacular; and I enjoyed the chance to meet and speak with many of the readers of DG. That being said, the doctor has a whole heck of a lot to write about in 2012; and hope you will continue to read and enjoy Dr. D’s diatribes.

Article 12 (European Databank) of the IVDD (98/79/EC), is all about propping up the European Economy with devalued dollars, courtesy of Uncle Sam, just kidding. Before the end of 2011, Dr. D wrote briefly on how the regulatory authorities in the European Union were getting much better at managing the flow of information as it pertained to device manufacturers, device registration, certificates, and vigilance reporting. Prior to May of 2011, use of the European Databank for Medical Devices (EUDAMED) was strictly voluntary. However, now use of EUDAMED is mandatory and the Competent Authorities, from each of the Member States, are required to input data into the databank. Wow, data in a databank, who knew?

Another salient point to comprehend is that the use of EUDAMED is not specific to the IVDD, but employed for all devices distributed within the EU (multiple Directives). Not wanting to date myself, Dr. D can remember when the zeitgeist (look-it-up) of the medical device industry of the latter part of the 20th Century (circa late1980s/early1990s), in the EU, was one of minimal regulatory oversight. The regulatory approach in the EU has changed significantly as technology continues to evolve; and the rescript of regulations to ensure the ongoing safety and efficacy of medical devices continues to occur more frequently. Long gone are the days of minimal oversight; and the inability for regulatory authorities in the EU to connect the proverbial dots when problem devices flooded the European market.

The IVDD – 98/79/ECArticle 12 – European Databank

1. Regulatory data in accordance with this Directive shall be stored in a European databank accessible to the competent authorities to enable them to carry out their tasks relating to this Directive on a well informed basis. The databank shall contain the following:

(a) data relating to registration of manufacturers and devices in accordance with Article 10;

(b) data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused according to the procedure as laid down in Annexes III to VII;

(c) data obtained in accordance with the vigilance procedure as defined in Article 11.

2. Data shall be forwarded in a standardized format.

3. The procedures implementing this Article shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).

What IVD medical device manufacturers need to knowThe salient concept associated with Article 12 pertains to the three words in the opening paragraph of Article 12, “well-informed basis.” These three words clearly imply the intent of this Article and the need to ensure the Competent Authorities are well-informed.” In short, the intent of the databank is for it to contain four (4) salient pieces of information that can be quickly accessed upon demand. These are:

Information (data) on the name and address of manufacturers or the manufacturer’s EU Rep address (if applicable);

Information on devices approved for distribution (CE Marked) in Europe;

Another important feature of EUDAMED is that the data loaded will be premised on the use of the Global Medical Device Nomenclature (GMDN). It is extremely important, as part of the device application process, the correct GMDN is used to identify product. When in doubt, ask your notified body, after all you are paying them for this support.

What IVD medical device manufacturers need to doFrom Dr. D’s perspective I will keep what device manufacturers need to do simple, only because complying with Article 12 is, in fact, simple. For starters, device manufacturers that do not have a manufacturing facility in one of the 27 Member States, must select and contract with a European Authored Representative. Simply stated; “No EU Rep, no business in the EU.”

Next up, product information supporting compliance to essential requirements is a fundamental requirement for obtaining a CE Mark. Simply stated; “No CE Mark equates to no product entry into the EU.” Thirdly, device manufacturers must ensure that their product is approved for entry into the EU Market. Simply stated; “No product certificates received from the notified body equates to no CE Mark, which equates to no product entry into the EU.” Finally, manufacturers of IVDD product must design, develop, and manufacture devices that are safe and effective in their intended use. Simply stated; “Devices that are safe and effective will not be racking up stacks of vigilance reports.”

TakeawaysThe primary takeaway for this edition of DG is that the population of device related data, including vigilance reporting, by the Competent Authorities, into EUDAMED is now mandatory. All of the Member States have access to this information so it is incumbent upon IVDD manufacturers to comply with all aspects of the IVDD. In the eyes of Dr. D, the best way IVDD manufacturers can support their position of compliance is through the design, development, and manufacture of devices that are safe and effective in their intended use.

Until the next installment of DG, when Dr. D provides insight and guidance into complying with Article 13 (Particular Health Monitoring Measures) of the In Vitro Diagnostic Medical Device Directive, a.k.a., IVDD – cheers from Dr. D and best wishes for continued professional success.

References:

Commission Decision 2010/227/EU. (2010, April). Commission decision of 19 April 2010 on the European Databank on Medical Devices (Eudamed). Retrieved December 9, 2011, from http://eur-lex.europa.eu.

Directive 98/79/EC. (1998, October). Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices Retrieved September 12, 2011, from http://eur-lex.europa.eu.

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About The Author

Dr. Christopher Joseph Devine is the President of Devine Guidance International, a consulting firm specializing in providing solutions for regulatory compliance, quality, supplier management, and supply-chain issues facing the device industry. Dr. Devine has 32 years of experience in quality assurance, regulatory compliance and program management. He is a senior member of the American Society for Quality (ASQ), a member of the Regulatory Affairs Professionals Society (RAPS), and a member of the Project Management Institute, and resides on several technical advisory boards. Dr. Devine received his doctorate from Northcentral University, with his doctoral dissertation titled, “Exploring the Effectiveness of Defensive-Receiving Inspection for Medical Device Manufacturers: A Mixed-Method Study.” Dr. Devine holds a graduate degree in organizational management (MAOM) and an undergraduate degree in business management (BSBM).

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